Tenet (Delray Medical Center (DMC) and St. Mary's Medical Center (SMH)) Research Process Guidelines

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Minimum Requirements

Responsibilities for Clinical Research

Continuing Medical Education / Graduate Medical Education

PI Initiated Registry Research Protocol Development (Pre Review Process)

When Resident will be Sharing Data

IRB Process

Facility Research Committee (FRC) Approval Process

Contacts

Human subjects research involving patient data from the Delray Medical Center (DMC), St. Mary's Medical Center (SMMC), or other Tenet Healthcare facilities must be approved by a Tenet facility. The principal investigator (PI) must be an attending physician on staff at a Tenet hospital (DMC or SMMC). The PI must obtain hospital approval and sign off on all submissions. Research and Scholarship completed at DMC/SMH will typically go through the FAU IRB. There may be times when Tenet's IRB (Metro West) may be utilized. This will be determined on a case-by-case basis.

Minimum Requirements

Master Agreement with TENET should be in place that speaks to research being conducted.  

Ensure the PI is affiliated with Tenet Physician who has a faculty appointment with the University that has a Master Agreement affiliated with hospital where you will be conducting research.

FAU Residents/Medical Students: PI is affiliated with DMC/SMH and has a faculty appointment with FAU.

To conduct research at Tenet, appropriate research credentialing is required. Tenet will provide CITI training access for those residents/fellows who are doing research (PI initiated or Sponsor initiated under PI) with a Tenet facility under the guidance of Tenet Physician/FAU Faculty member who is overseeing their work at a Tenet hospital/practice. 

    1. Log on to citiprogram.org and affiliate with Palm Beach Health Network (Tenet). 
    2. Complete the following courses:
      1. Good Clinical Practice (GCP): GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
      2. Human Subject Research (HSR): Biomedical (Biomed) Comprehensive
      3. Conflicts of Interest (COI): COI in HealthCare
    3. Save your CITI Certificates and remember to keep track of expiration dates as they are not all the same.

CITI Help Desk: 888-529-5929 (U.S. toll free)

A. Responsibilities for Clinical Research

All clinicians and employees are obligated to know the ethical principles and practices of clinical research and follow all Office of Human Research Protections (OHRP) and Centers for Medicare and Medicaid Services (CMS) regulatory guidelines as required by the Institutional Review Board of record and Hospital Clinical Research Office.

Assures all research is safe and ethical, complies with Medicare Billing rules, and abides under the Health Insurance Portability and Accountability Act (HIPAA);  Provides researchers with pricing information for their clinical study budgets; Requires and retains documentation that all research approved and monitored by the IRB; Monitors patient enrollment in interventional studies for safety, billing, and auditing purposes

B. Continuing Medical Education (CME) / Graduate Medical Education (GME)

Please reach out to the following contacts to complete the appropriate hospital requirements.

C. PI Initiated Registry Research Protocol Development (Pre Review Process)

  1. Define question/hypothesis.
  2. Define applicable data set requirements, including dates for record review period, and ensure data set is available with Institution.
  3. Review, finalize, and communicate with Faculty Advisor, Principal Investigator, Clinical Mentor, Research Methodologist, and Program Director. 
  4. Review application for completeness, methods and adherence to ethical standards.
  5. Resident sends final version of application to the IRB (if determined that it is not exempt) Research Department Pre-Review.

D. When Resident will be Sharing Data

Contact site's Research Department for appropriate form and agreement requirements.

  1. Prior to Data Use Agreement (DUA)
    1. Checklist to be completed, and signed by PI
    2. Trauma Research: When site meets all specifications outlined below PI/Research Coordinator is no longer required to submit the DUA/Registry Checklist to Director of Research/NRBO/Corporate for approval.
      • Sites that maintain level 1 Trauma Accreditation (St. Mary’s and Delray Medical Centers in Palm Beach County)
      • PI is the treating physician
      • No financial compensation
      • Hospital designated research staff (RC, Medical students/Residents involved in trauma rotation) all of whom are under PI oversight would ensure data collected would be de-identified prior to uploading, entering information into an electronic data capture.
      • IRB approved studies
      • Not a direct competitor
      • If there is any doubt, the designated Research Manager must submit a DUA/Registry checklist with supporting documentation to Lisa Wettermann (Group Director) for final review. After reviewing documents, the request will be submitted to the NRBO who will forward the request to corporate for evaluation/approval of the research project. I have no problem with RC creating drafts, but the manager needs to review. Once reviewed/PI should sign and send it to the manager.
    3. DUA/Data Sharing Agreement will need to be in place after review/approval by legal. Previous emails have gone out to managers on guidance of what type of agreement to use when outside site does not have their Data Use Agreement.
  2. Data Use Agreement/Data Sharing Agreement-reach out to research department manager at the site you are conducting research for assistance
  3. Execute Data Use Agreement after Legal has reviewed and approved

E. IRB Process

You may NOT begin engaging in human subject research without IRB approval.

Research categories:
Full IRB Review, Expedited Review, and Exempt Review

Types of Document Reviews that need to be submitted for IRB review:
Initial and Continuing Review, Modifications/Amendments, Adverse/Serious Adverse Events, Non-compliance

Steps:

  1. Complete IRB application, electronically attach instruments, consent forms, and all applicable documents.  FAU residents will follow FAU’s IRB processes. Residents/Medical Students not affiliated with FAU, please check with the Research Manager at your site for guidance.
  2. Submit materials to IRB
  3. Communicate with reviewer to revise application, if necessary.
  4. Notifies the Investigator via email that application has arrived at the IRB office.
  5. IRB office's process:
    • Reviews level recommendation and evaluates the application for compliance with federal regulations.
    • Verifies training requirements: CITI training requirements, CV, License
    • Communicates with Investigator regarding any additional requirements, or revisions needed.
    • Sends final written notification of IRB determination to Investigator.
  6. Upon study closure, ensure destruction of data according to IRB of record, submit IRB closure request, and inform site that study is closed.
  7. Provide site a copy of IRB closure letter.
  8. Provide site copy of presentation, paper, poster, and/or publication that resulted in project.

Case Studies (for Medical Students):

Tenet IRB (Metro West) WILL NOT charge FAU or Tenet for case studies (up to 5 patients)

IRB Case Review Submission Checklist and Forms available (upon request to Site Research Manager)

F. Facility Research Committee (FRC) Approval Process

  1. The Facility Research Committee (FRC) will review all research submissions.
  2. Resident/Medical Student expected to present study/project to the FRC meeting.
  3. FRC Submission form(s), IRB submission form, and the Protocol Synopsis (at a minimum-may require more information) must be reviewed by your Clinical Mentor, Research Methodologist, Program Director, and Principal Investigator prior to submitting forms/synopsis to FRC.
    1. Delray:  FRC meeting will occur on the 2nd Tuesday of every month at 1:00pm. FRC meetings are held in the Medical Resident Conference Room next to administration.
    2. St. Mary's:  FRC meeting will occur on the Third Thursday of every month. Location changes depending on availability. Invitation will go out ahead of time with location.
  4. FRC submission due no later than one week prior to committee meeting at presenting facility.
  5. Voting will occur after presentation to approve/deny request. Letter of determination will be sent out to presenter/PI via email (please make sure this is provided with submission request).
  6. Once you receive the FRC approval letter of cooperation, you will need to add it to your IRB package.
  7. Send IRB letter (approval or exempt) to site Research Manager for record of documentation (FAU/Metro West IRB).
  8. Send notification of Study closure to site Research Manager for record of documentation (FAU/Metro West IRB)

Contacts

DMC Facility Research Committee

SMMC Facility Research Committee

MetroWest IRB

Charles E. Schmidt College of Medicine

The Charles E. Schmidt College of Medicine offers medical degrees through seven departments, as well as Master and Ph.D. programs.

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